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Recruiting NCT03913819

NCT03913819 Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction

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Clinical Trial Summary
NCT ID NCT03913819
Status Recruiting
Phase
Sponsor Chinese University of Hong Kong
Condition Voiding Dysfunction
Study Type OBSERVATIONAL
Enrollment 1,000 participants
Start Date 2011-12-10
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age N/A
Study Type OBSERVATIONAL
Interventions
First line treatment: oral NSAID and anticholinergic agentsSecond line treatment: additional treatment for pain controlThird line treatment: A course of intravesical hyaluronate will be given.

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 1,000 participants in total. It began in 2011-12-10 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

With the increase of substance abuse over the world, substance abuse e.g. ketamine and methamphetamine related voiding dysfunction is becoming an important medical problem. However, while the clinical manifestation of the condition is becoming better defined, the underlying pathophysiology is still poorly understood. Moreover, majority of the current treatment is just based on the experience on some small case series and there is no treatment data for larger patient sample or standard recommended treatment in the literature. In order to improve the management of this condition, investigators have formulated a treatment protocol based on the current literatures on the management of voiding dysfunction and also a similar condition, interstitial cystitis / painful-bladder syndrome (IC/PBS). The protocol basically consists of the following modalities: * Basic information and education on the condition, principle of treatment and psychosocial support. * First line treatment will include a course of oral anti-inflammatory drugs (for the control of the inflammation process and pain) and anticholinergic agents (for the irritative urinary symptoms). * If these simple oral medication are found to be not effective, then further treatment will include other oral medications, such as amitriptyline and gabapentin, and some drugs that directly applied into the bladder cavity (hyaluronate) or bladder muscle (botulinum toxin). * For those patients with intractable symptoms and failed all the above treatments, surgical treatment (hydrodistension, augmentation cystoplasty) will be discussed. The purpose of this research is to assess the effectiveness of the above treatment protocol in the management of substance induced voiding dysfunction and also assess any possible adverse events related to the usage of the drugs.

Eligibility Criteria

Inclusion Criteria: * Patients suffered substance abuse induced voiding dysfunction Exclusion Criteria: * Patient not agreed for consent * Patient that will not comply to our treatment protocol

Contact & Investigator

Central Contact

Chi Fai Ng, MD

✉ ngcf@surgery.cuhk.edu.hk

📞 852-3505-2625

Frequently Asked Questions

Who can join the NCT03913819 clinical trial?

This trial is open to participants of all sexes, studying Voiding Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03913819 currently recruiting?

Yes, NCT03913819 is actively recruiting participants. Contact the research team at ngcf@surgery.cuhk.edu.hk for enrollment information.

Where is the NCT03913819 trial being conducted?

This trial is being conducted at Shatin, Hong Kong.

Who is sponsoring the NCT03913819 clinical trial?

NCT03913819 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 1,000 participants.

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